(88 days)
Use of the device is indicated for the incision, excision, ablation, vaporization and coagulation of dermatologic tissues including epidermal nevi, cheilitis, keloids, verrucae, skin tags, keratosis, scar revision, debulking of tumors, cysts, diagnostic biopsy and skin resurfacing. Use of the device is further indicated for the incision, excision, vaporization and coagulation of soft tissue during general surgical applications where skin incision, tissue disection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors and lesions, tissue ablation and/or vessel coadulation may be indicated
The DermaLase ™ laser system consists of two main components: the laser module and the delivery system. The Laser Module contains the laser resonator cavity, power supplies, closed loop internal cooling system and TTCS™ tissue irrigation and cooling module. Microelectronics circuits and system Control Panel are housed inside the laser console as well. The Control Panel provides access to all system controls. Actions are initiated through a touch sensitive membrane keypad. The display screen is back lighted for easy viewing. BioLase currently offers two options for laser energy delivery: a fiber optic based delivery system and an articulated arm based delivery system. The fiber optic system utilizes either a contact or non-contact hand piece. The articulated arm based delivery system utilizes either a contact or non-contact point delivery hand piece.
The provided text is a 510(k) summary for the DermaLase™ laser system, which focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a study with specific acceptance criteria and performance metrics in the way a clinical trial for a new drug or a novel AI diagnostic device would.
Therefore, the requested information cannot be fully extracted as there is no detailed study described that measures the device's performance against pre-defined acceptance criteria with specific metrics like sensitivity, specificity, or inter-rater reliability. The 510(k) process for this device relies on demonstrating that the DermaLase™ is as safe and effective as other legally marketed devices, primarily the Elmer™ laser system (K952118), and other similar erbium lasers.
Here's a breakdown of what can be inferred or directly stated from the provided document, and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance:
This information is not available in the provided document. A 510(k) summary for a device like a surgical laser typically focuses on comparing its technical specifications and intended use to predicate devices, rather than establishing numerical performance metrics against acceptance criteria.
2. Sample Size Used for the Test Set and Data Provenance:
This information is not applicable/not available. The document does not describe a "test set" in the context of evaluating the device's performance against a gold standard for a specific medical outcome. The submission relies on a comparison of device specifications and indications for use with predicate devices.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
This information is not applicable/not available. The document does not describe a study involving human readers or experts establishing ground truth for a test set.
4. Adjudication Method:
This information is not applicable/not available. There is no adjudication method described as no study involving human assessment of results is mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
This information is not applicable/not available. The document does not describe a MRMC study or any study comparing human readers with and without AI assistance. The DermaLase™ is a surgical laser, not an AI diagnostic device.
6. Standalone Performance:
This information is not applicable/not available in the sense of an algorithm's standalone performance. The document describes the device itself and its equivalence to other lasers. Its "standalone performance" is inherent in its technical specifications (wavelength, power, frequency) which are deemed equivalent to predicate devices.
7. Type of Ground Truth Used:
This information is not applicable/not available in the context of a performance study. For this type of 510(k) submission, the "ground truth" is essentially established by the safety and effectiveness profile of the predicate devices. The claim is that the new device operates similarly and therefore achieves similar clinical outcomes as the predicates.
8. Sample Size for the Training Set:
This information is not applicable/not available. Training sets are relevant for machine learning algorithms. The DermaLase™ is a physical surgical laser, not an AI system that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable/not available as there is no training set for this type of device.
Summary derived from the provided text regarding Substantial Equivalence:
The DermaLase™ laser system's acceptance criteria are implicitly defined by its substantial equivalence to existing, legally marketed devices. The study proving this involves a comparison of its technical specifications and intended uses to those predicate devices.
Predicate Devices:
- CB Erbium/2.94 (Continuum Biomedical, Inc.) - K961748
- Trilase 2940™ Erbium laser system (Schwartz Electro-Optics) - K954013
- MCL 29 Dermablate™ (Aesculap-Meditec) - K964128
- Elmer™ (BioLase Technology, Inc.) - K952118 (mentioned as almost identical)
Key Aspects of Comparison (implicitly the "study" for 510(k)):
- Wavelength, Power, and Frequency: The DermaLase™ produces laser light at the exact same wavelength, power, and frequency as the Elmer™ (K952118). This is a primary technical equivalence point.
- Tissue Irrigation and Cooling System: The DermaLase™ includes BioLase's Target Tissue Cooling System™ for tissue cooling and irrigation, which is equivalent to that found in the Elmer™ (K952118).
- Indications for Use: The DermaLase™ is indicated for "incision, excision, ablation, vaporization and hemostasis of soft tissue." The submission states that similar indications for use are shared with predicate devices like those from Schwartz Electro-Optics, Continuum Biomedical, and Aesculap-Meditec. The specific expanded indications listed in the FDA's "Indications For Use" form include dermatologic tissues and general surgical applications (incision, excision, vaporization, coagulation of soft tissue, etc.).
- Safety and Effectiveness: The conclusion drawn is that because the DermaLase™ shares similar performance specifications, design, and indications for use with legally marketed predicate devices, it is considered as safe and effective.
Conclusion:
The provided 510(k) summary does not contain the detailed performance study information with explicit acceptance criteria, sample sizes, and ground truth methodologies typically associated with clinical trials or AI device evaluations. Instead, the "study" is a demonstration of substantial equivalence through a comparison of the DermaLase™'s design, technical specifications, and intended uses to those of predicate devices already cleared for market.
{0}------------------------------------------------
DermaLase™ BioLase Technology, Inc. April 18, 1997
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
REGULATORY AUTHORITY:
Safe Medical Devices Act of 1990, 21 CFR 807.92
JUL 1 8 1997
COMPANY NAME/CONTACT:
- BioLase Technology, Inc. Company: 981 Calle Amanecer San Clemente, California 92673
- Contact: Mr. Andrew Kimmel BioLase Technology, Inc. 981 Calle Amanecer San Clemente, California 92673 (714) 361-1200 (714) 361-0204 Fax
Trade Name:
Common Name:
Surgical Laser
DermaLase™
Classification Name:
Surgical Laser System
Classification 79GEX Code:
EQUIVALENT DEVICES:
| CB Erbium/2.94 | Continuum Biomedical, Inc. | K961748 |
|---|---|---|
| Trilase 2940™ Erbium laser system | Schwartz Electro-Optics | K954013 |
| MCL 29 Dermablate™ | Aesculap-Meditec | K964128 |
| Elmer™ | Biolase Technology, Inc. | K952118 |
DESCRIPTION OF THE DEVICE:
The DermaLase ™ laser system consists of two main components: the laser module and the delivery system.
The Laser Module contains the laser resonator cavity, power supplies, closed loop internal cooling system and TTCS™ tissue irrigation and cooling module. Microelectronics circuits and system Control Panel are housed inside the laser console as well.
{1}------------------------------------------------
The Control Panel provides access to all system controls. Actions are initiated through a touch sensitive membrane keypad. The display screen is back lighted for easy viewing.
BioLase currently offers two options for laser energy delivery: a fiber optic based delivery system and an articulated arm based delivery system. The fiber optic system utilizes either a contact or non-contact hand piece. The articulated arm based delivery system utilizes either a contact or non-contact point delivery hand piece.
Indications for Use:
Use of the Dermalase ™ laser system is restricted to the incision, excision, ablation, vaporization and hemostasis of soft tissue
SUBSTANTIAL EQUIVALENCE:
This Premarket Notification demonstrates that the laser systems described herein are substantially the same as the DermaLase 7M laser system.
Several different surgical, dental and dermatological laser systems and features are equivalent to those of the DermaLase™ laser unit. The internal components of the DermaLase 14 are almost identical to an earlier, currently 510(k) cleared Biolase erbium laser product, Elmer™ (K952118). The Elmer™ laser system produces laser light at the exact same wavelength, power and frequency as the DermaLase™ and includes Biolase's Target Tissue Cooling System™ for tissue cooling and irrigation.
Other laser manufacturers such as Schwartz Electro-Optics, Continuum Biomedical and Aesculap-Meditec are currently marketing products with similar performance specifications as the DermaLase ™ and for similar indications for use.
CONCLUSION:
The DermaLase™ is Substantially Equivalent to several available surgical laser systems. As noted above, the laser wavelength and air and water fissue cooling and urrgation spray are equivalent to an earlier Biolase product, Elmer™ (K952118). Several other equivalent erbium laser devices have similar performance specifications, promotional materials and indications for use.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract emblem that resembles an eagle or other bird-like figure, composed of several curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 8 1997
Mr. Andrew Kimmel BIOLASE Technology, Inc. ... 981 Calle Amanecer San Clemente, California 92673
Re: K971459
Trade Name: DermaLase Er, Cr:YSGG Laser with Contact and Non-contact Handpieces Regulatory Class: II Product Code: GEX Dated: April 18, 1997 Received: April 21, 1997
Dear Mr. Kimmel:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
{3}------------------------------------------------
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits vour device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801. and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 554-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
t.coellefa
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Page 1 of 1
..............................................................................................................................................................................
510 (K) Number (if known): K971459
DIGLINE THE TECH
Device Name:
DermaLase
Indications For Use: . . . . . . .
Use of the device is indicated for the incision, excision, ablation, vaporization and coagulation of dermatologic tissues including epidermal nevi, cheilitis, keloids, verrucae, skin tags, keratosis, scar revision, debulking of tumors, cysts, diagnostic biopsy and skin resurfacing.
Use of the device is further indicated for the incision, excision, vaporization and coagulation of soft tissue during general surgical applications where skin incision, tissue disection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors and lesions, tissue ablation and/or vessel coadulation may be indicated
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | K971459 |
| 510(k) Number |
Prescription Use (Per 21 CFR 801.109) க
Over-The-Counter Use - -
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.